Temozolomide Sandoz

Medicinal product

(Invented) name

Temozolomide Sandoz

Active substance (s)

Temozolomidas

Strength

5 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AX03, Temozolomide

Marketing authorisation holder

Sandoz GmbH, Austrija

Date of authorisation

2010-03-15

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Temozolomidas	5 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
40756	54493	1054493	buteliukas	N5 (stiklo)		Receptinis	EU/1/10/617/001	Netiekiama	-	-	No	-	-
40757	54494	1054494	buteliukas	N20		Receptinis	EU/1/10/617/002	Netiekiama	-	-	No	-	-
53681	67664	1067664	paketėlis	N5x1 (vienadozis)		Receptinis	EU/1/10/617/025	Netiekiama	-	-	No	-	-
53682	67665	1067665	paketėlis	N20x1 (vienadozis)		Receptinis	EU/1/10/617/026	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-15	Išregistruotas
2010-03-15	Registruotas